1. Field of the Invention
The present invention relates generally to pharmaceutical vial and cap assemblies. More particularly, the present invention relates to a tamper-resistant assembly which clearly indicates accidental or intentional tampering or contamination.
2. Brief Description of the Prior Art
In retail outlets, hospitals, clinics, and other health care facilities, a wide variety of medications and other pharmaceuticals are delivered or administered to patients for oral ingestion. Oral administration generally requires that a pharmaceutical dose be deposited in a vial in the pharmacy or health care facility, from which it is transported to the patient and ultimately administered. This procedure provides many opportunities for contamination, spillage, or outright tampering, since efficient operation of the drug store, manufacturer or pharmacy makes it desirable to pre-fill a number of vials of a given medication at one time, even though the products are displayed on a shelf for sale or the hospital use may be spread out over several days. If the vials are sealed at the time of filling, the customer, patient or nurse may experience difficulty in opening a vial at the time of administration, depending upon the type and construction of seal employed. Contamination before, during and after filling is a persistent problem. Post-filling tampering or contamination, which may involve removal of part of the contents of a vial, contamination through addition to the contents of the vial, or even complete substitution, is possible.
A number of different constructions are known for sealed vials. Some of these devices employ caps or closures of multipart construction, involving a molded stopper of elastomer or resin material in conjunction with a clamping ring to hold the stopper in place. Additional elements, such as resin or metal covering discs, are commonly used in conjunction with the principal stopper and clamp ring. Access to the vial interior is frequently provided by a slit valve or other opening in the stopper. Devices of this kind are disclosed in Campbell U.S. Pat. No. 2,236,491, Breakstone U.S. Pat. No. 2,579,724, Roberts U.S. Pat. No. 2,797,837, Gould U.S. Pat. No. 3,013,687, Reimann U.S. Pat. No. 3,067,898, Hershberg et al U.S. Pat. No. 3,424,329, Wimmer U.S. Pat. No. 3,653,528, Westfall U.S. Pat. No. 3,690,499, Zackheim U.S. Pat. No. 3,823,840, and in Cantrill British Pat. No. 602,763.
A unit dose vial used for oral administration of pharmaceuticals is describd in Handman U.S. Pat. No. 4,244,478, issued Jan. 13, 1981. This patent discloses an elastomer stopper which seals the vial and affords a rim covering the lip of the vial, together with a metal sealing ring crimped onto the vial and covering the stopper rim. The stopper has a self-venting self-sealing linear slit valve that allows filling of the vial with the stopper in place. The seaing ring includes an integral release tab permitting quick and convenient removal of both the ring and the stopper for oral administration of the vial itself.
Another container and closure assembly adaptable to unit dose vials is described in Miskin U.S. Pat. No. 3,595,420, issued July 27, 1971, in which an open-top vial is covered by a resilient molded cap that has an integral skirt encompassing the upper portion of the vial. The inner surface of the skirt and the outer surface of the vial have complementary mating interlock elements that preclude manual removal of the cap from the vial. The cap comprises a tear member defined by one or more weakened junction lines molded into the skirt. Complete removal of the tear member permits convenient removal of the cap from the vial at the time of administration while, at the same time, may disguise any tampering.
These prior art devices commonly prevent contamination of the interior of the vial prior to and during filling. Frequently, the same devices also prevent casual contamination of the contents of the vial after filling. Indeed, this is true of most of the prior art devices noted above. The Miskin device, on the other hand, provides no protection for the vial before filling, but generally discloses any post-filling tampering with the contents of the vial, whether by way of extraction from or addition to the vial. Another common drawback of these prior art devices is a direct result of their multipart construction. Often the element intended to preclude tampering is completely removed upon administration of the pharmaceutical. Since this protective element is usually missing after the vial has been opened, nurses and, more particularly, patients unfamiliar with the appearance of an intact tamper-resistant device, would have no obvious way of knowing that a vial has been opened.
It was noted that a major reason for the development of these tamper-resistant pharmaceutical vials is that it is more efficient and therefore desirable for a pharmacy to prefill a large number of vials with a given unit dose of medication. This is partially because administrative regimens often continue over several days, and further, because many patients are often on substantially identical regimens. For these reasons it is also desirable to provide a tamper-resistant pharmaceutical vial that can be filled automatically by well known filling machines.
Ideally, a vial intended for oral administration of pharmaceuticals should permit both manual and automatic filling with the vial closure already in place to maintain the vial in clean and sterile condition. At the same time, the vial assembly should permit rapid and convenient removal of the vial cap, by either a nurse or a patient, for oral administration of the pharmaceutical. The vial and closure assembly also should prevent any casual contamination of the contents of the vial after it has been filled and should preclude tampering by addition to, removal from, or even complete substitution for the contents of the vial.
Finally, the vial and closure assembly should clearly communicate the occurrence of any intentional or accidental post-filling tampering or contamination of the contents. These somewhat conflicting requirements have not been fully and effectively met in any single vial and closure assembly of the prior art.